A Study of the Efficacy of Genakumab in Prevention of Acute Flares in Gout Patients Initiating Urate-lowering TherapyUrate-lowering (GenSci048-202)
NCT ID: NCT05936281
Last Updated: 2025-01-01
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
165 participants
INTERVENTIONAL
2023-07-20
2024-01-19
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Genakumab group
Genakumab 100mg single injection、Genakumab 200mg single injection
Genakumab for injection
150 mg/1ml/ vial
Colchicine group
Oral colchicine 0.5mg once a day for 12 weeks
Colchicine
0.5 mg/table
Interventions
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Genakumab for injection
150 mg/1ml/ vial
Colchicine
0.5 mg/table
Eligibility Criteria
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Inclusion Criteria
2. Male or female, 18 years ≤ age ≤ 75 years.
3. BMI ≤ 40kg/m2.
4. Confirmed diagnosis of gout meeting the American College of Rheumatology (ACR) 2015 preliminary criteria for the classification of arthritis of primary gout.
5. History of ≥2 gout flare within 12 months prior to screening.
6. Willingness to initiate urate-lowering therapy or having initiated urate-lowering therapy within 1 week prior to screening
18 Years
75 Years
ALL
No
Sponsors
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Huashan Hospital
OTHER
Changchun GeneScience Pharmaceutical Co., Ltd.
INDUSTRY
Responsible Party
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Principal Investigators
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Hejian Zou
Role: PRINCIPAL_INVESTIGATOR
Fudan University Affiliated Huashan Hospital
Locations
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Fudan University Affiliated Huashan Hospital
Shanghai, Shanghai Municipality, China
Countries
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Other Identifiers
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GenSci 048-202
Identifier Type: -
Identifier Source: org_study_id
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